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Spinal Cord Stimulation Business Case for Failed Back Surgery Syndrome

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Spinal Cord Stimulation Business Case for Failed Back Surgery Syndrome

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    1. Spinal Cord Stimulation Business Case for Failed Back Surgery Syndrome This report reviews current published medical research and other literature to present the socioecomonic issues associated with treating patients with chronic pain, particularly chronic low back pain and failed back surgery syndrome (FBSS). These complex issues challenge the needs of various stakeholders, such as patients, healthcare providers, and employers. This report aims to analyze the costs and benefits of spinal cord stimulation (SCS) therapy and to credibly present SCS as a viable early option for treating FBSS. Additionally, the published literature will show how SCS can effectively satisfy the needs of stakeholders associated with FBSS.This report reviews current published medical research and other literature to present the socioecomonic issues associated with treating patients with chronic pain, particularly chronic low back pain and failed back surgery syndrome (FBSS). These complex issues challenge the needs of various stakeholders, such as patients, healthcare providers, and employers. This report aims to analyze the costs and benefits of spinal cord stimulation (SCS) therapy and to credibly present SCS as a viable early option for treating FBSS. Additionally, the published literature will show how SCS can effectively satisfy the needs of stakeholders associated with FBSS.

    2. Understanding How Various Stakeholders Gauge Success in Treating Chronic Pain Chronic pain is the broadest condition of the three and refers to pain that - Exists one month longer than expected - Persists after the expected healing time - Can be physically and emotionally debilitating, reducing a person’s quality of life Chronic low back pain is a type of chronic pain that more specifically refers to pain that - Can originate from the spine, muscles, or nerves, and may radiate from areas such as the mid- or upper back - Causes a tingling feeling, burning sensation, dull aching, or a sharp pain FBSS is a narrower subset of chronic low back pain; patients with FBSS - Experience chronic, disabling low back pain with or without leg pain - Have undergone at least one decompressive procedure of the lumbar spine (but frequently have undergone multiple procedures)Chronic pain is the broadest condition of the three and refers to pain that - Exists one month longer than expected - Persists after the expected healing time - Can be physically and emotionally debilitating, reducing a person’s quality of life Chronic low back pain is a type of chronic pain that more specifically refers to pain that - Can originate from the spine, muscles, or nerves, and may radiate from areas such as the mid- or upper back - Causes a tingling feeling, burning sensation, dull aching, or a sharp pain FBSS is a narrower subset of chronic low back pain; patients with FBSS - Experience chronic, disabling low back pain with or without leg pain - Have undergone at least one decompressive procedure of the lumbar spine (but frequently have undergone multiple procedures)

    3. FBSS Comorbidities

    4. Understanding How Various Stakeholders Gauge Success in Treating Chronic Pain This table depicts briefly and generally how various stakeholders determine if a treatment option for chronic pain is successful. A successful treatment option should meet as many of the criteria shown here as possible. This table depicts briefly and generally how various stakeholders determine if a treatment option for chronic pain is successful. A successful treatment option should meet as many of the criteria shown here as possible.

    5. How Low Back Pain Impacts Society Based on the stakeholder analysis mentioned here, low back pain challenges society by preventing a patient from returning to work. According to a study by Katz, “80 percent of workers who report an episode of low back pain return to work within one month. More than 90 percent return by 3 months. Fewer than 5 percent never return.”6 Of the remaining 5 percent of people who report low back pain, the longer they remain out of work, the less likely they are to return. Katz reports, “By the time a worker has been out of work for 6 months, the likelihood of return to work is just 50 percent. And by the time the worker has been out of work for one year, the likelihood of ever returning to work drops to 25 percent.”2 Based on the stakeholder analysis mentioned here, low back pain challenges society by preventing a patient from returning to work. According to a study by Katz, “80 percent of workers who report an episode of low back pain return to work within one month. More than 90 percent return by 3 months. Fewer than 5 percent never return.”6 Of the remaining 5 percent of people who report low back pain, the longer they remain out of work, the less likely they are to return. Katz reports, “By the time a worker has been out of work for 6 months, the likelihood of return to work is just 50 percent. And by the time the worker has been out of work for one year, the likelihood of ever returning to work drops to 25 percent.”2

    6. How Low Back Pain Impacts Employers and Other Payers According to the American Journal of Public Health, “Of the 149.1 million work days lost as a result of back pain cases, 101.8 million (68 percent) were lost by individuals with work-related cases.”3 According to the American Journal of Public Health, “Of the 149.1 million work days lost as a result of back pain cases, 101.8 million (68 percent) were lost by individuals with work-related cases.”3

    7. Costs to Disability and Workers’ Compensation Back pain is the most common cause of work-related disability in people under 45.Back pain is the most common cause of work-related disability in people under 45.

    8. How Low Back Pain Impacts the Economy and Healthcare The National Institutes of Health (NIH)5 estimates that low back pain alone costs the U.S. economy over $100 billion annually and is a top reason for patients to see a doctor, second only to the common cold. This economic burden has continued to rise since 1997.The National Institutes of Health (NIH)5 estimates that low back pain alone costs the U.S. economy over $100 billion annually and is a top reason for patients to see a doctor, second only to the common cold. This economic burden has continued to rise since 1997.

    9. How Low Back Pain Impacts the Economy and Healthcare

    10. As of 2004, low back pain was the4 Second leading symptomatic cause for physician visits Third most common cause for surgical procedures Fifth most common reason for hospitalizations According to a study by Katz,2 the 5 percent of patients who have low back pain who do not return to work by 3 months account for 75 percent of total healthcare costs. Direct costs included medications, hospitalizations, and outpatient visits, while indirect costs included lost wages, decreased productivity, and caregiver expenses.According to a study by Katz,2 the 5 percent of patients who have low back pain who do not return to work by 3 months account for 75 percent of total healthcare costs. Direct costs included medications, hospitalizations, and outpatient visits, while indirect costs included lost wages, decreased productivity, and caregiver expenses.

    11. How Low Back Pain Impacts the Economy and Healthcare According to 2005 Healthcare Cost and Utilization Project (HCUP) data of all surgeries in the U.S.,7 surgeons performed nearly 1.3 million spinal surgeries. Of this total, studies8,9 showed that over 200,000 of these were lumbar spine surgeries, of which between 20 and 40 percent resulted in FBSS.According to 2005 Healthcare Cost and Utilization Project (HCUP) data of all surgeries in the U.S.,7 surgeons performed nearly 1.3 million spinal surgeries. Of this total, studies8,9 showed that over 200,000 of these were lumbar spine surgeries, of which between 20 and 40 percent resulted in FBSS.

    12. Complexities in Managing FBSS Overall from 1997 to 200310 Cervical fusions increased by 433 percent. Thoracolumbar fusions increased by 52 percent. Lumbar fusions increased by 356 percent.

    13. Current Medicare Criteria for Evaluating Spinal Cord Stimulation Candidates Spinal cord stimulation (SCS), a type of neurostimulation, is an FDA-approved option for treating chronic pain of the trunk and limbs, including chronic low back pain and FBSS. Additionally, Medicare reimburses costs for the SCS system and the procedure.Spinal cord stimulation (SCS), a type of neurostimulation, is an FDA-approved option for treating chronic pain of the trunk and limbs, including chronic low back pain and FBSS. Additionally, Medicare reimburses costs for the SCS system and the procedure.

    14. Current Continuum of Care for Failed Back Surgery Syndrome Similar to the Medicare requirements, many physicians consider SCS as a final-tier therapy along the current continuum of care for FBSS. Similar to the Medicare requirements, many physicians consider SCS as a final-tier therapy along the current continuum of care for FBSS.

    15. The Clinical and Economic Case For SCS According to a 2007 analysis, “In spite of the apparent clinical success of SCS reported in the literature and the data presented by the authors, there continues to be concern, particularly among third-party payers, that SCS is an expensive and even ineffective therapy.”12 According to a 2007 analysis, “In spite of the apparent clinical success of SCS reported in the literature and the data presented by the authors, there continues to be concern, particularly among third-party payers, that SCS is an expensive and even ineffective therapy.”12

    16. The Clinical and Economic Case for SCS Turk and McCarberg15 showed that SCS was more effective at relieving pain than pain rehabilitation programs, opioids, and antidepressants/anticonvulants. Turk and McCarberg15 showed that SCS was more effective at relieving pain than pain rehabilitation programs, opioids, and antidepressants/anticonvulants.

    17. The Clinical and Economic Case for SCS

    18. Reduction of Pain

    19. Reduction in Medication

    20. Improvements in Daily Activities

    21. Return to Work

    22. Cost-Effectiveness of SCS

    23. Cost-Effectiveness of SCS

    24. Cost-Effectiveness of SCS

    25. Importance of Timing With SCS in the Treatment of FBSS

    26. Importance of Timing With SCS in the Treatment of FBSS Another study by Kumar17 supports this statement. According to Kumar, the rate of success of neurostimulation is inversely correlated to the time between the start of chronic pain and the time a device is implanted. The success rate of neurostimulation decreased from about 85 percent if the procedure was performed within 2 years to about 9 percent if the procedure was delayed by 15 years or longer.Another study by Kumar17 supports this statement. According to Kumar, the rate of success of neurostimulation is inversely correlated to the time between the start of chronic pain and the time a device is implanted. The success rate of neurostimulation decreased from about 85 percent if the procedure was performed within 2 years to about 9 percent if the procedure was delayed by 15 years or longer.

    27. SCS could be an overall effective treatment option earlier in the continuum of care. Based on its clinically proven effectiveness as a treatment for FBSS and its viability as a cost-effective treatment in the long term, experts have demonstrated that SCS is increasingly effective the sooner the system is implanted. According to Mekhail, “Neurostimulation should be considered as a viable option for the early treatment of patients with intractable chronic neuropathic pain.”24SCS could be an overall effective treatment option earlier in the continuum of care. Based on its clinically proven effectiveness as a treatment for FBSS and its viability as a cost-effective treatment in the long term, experts have demonstrated that SCS is increasingly effective the sooner the system is implanted. According to Mekhail, “Neurostimulation should be considered as a viable option for the early treatment of patients with intractable chronic neuropathic pain.”24

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